Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2026-02-24 @ 5:50 AM
Study NCT ID:
NCT01535859
Status:
COMPLETED
Last Update Posted:
2018-08-07
First Post:
2012-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016471', 'term': 'Ovarian Hyperstimulation Syndrome'}], 'ancestors': [{'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077465', 'term': 'Cabergoline'}], 'ancestors': [{'id': 'D004873', 'term': 'Ergolines'}, {'id': 'D004876', 'term': 'Ergot Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-05', 'studyFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2012-02-17', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The development of moderate or severe OHSS necessitating admission for management of OHSS.', 'timeFrame': 'Within 2 weeks after hCG trigger'}], 'secondaryOutcomes': [{'measure': 'The need for abdominal or pleural tap', 'timeFrame': 'Within 3 weeks after hCG trigger'}, {'measure': 'Other complications of OHSS (venous thromboembolism, cardiac failure, renal failure, acute respiratory failure, pulmonary oedema and coma)', 'timeFrame': 'Within 3 weeks after hCG trigger'}, {'measure': 'Admission into intensive care', 'timeFrame': 'Within 3 weeks after hCG trigger'}, {'measure': 'Examination of potential biomarkers for OHSS', 'timeFrame': '1-2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Ovarian Hyperstimulation Syndrome']}, 'referencesModule': {'references': [{'pmid': '33851429', 'type': 'DERIVED', 'citation': 'Tang H, Mourad SM, Wang A, Zhai SD, Hart RJ. Dopamine agonists for preventing ovarian hyperstimulation syndrome. Cochrane Database Syst Rev. 2021 Apr 14;4(4):CD008605. doi: 10.1002/14651858.CD008605.pub4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether cabergoline is effective in reducing the incidence and severity of Ovarian Hyperstimulation Syndrome (OHSS), especially for severe cases; and to derive biomarkers for the risk of developing OHSS.', 'detailedDescription': 'Severe ovarian hyperstimulation syndrome (OHSS) occurs in up to 2% of in-vitro fertilisation (IVF) cycles, resulting in accumulation of fluid in peritoneal, pleural and pericardial cavities, haemo-concentration with resultant venous thromboembolic phenomena, reduced perfusion of vital organs, renal failure, acute respiratory failure, and even death.\n\nThe long term aim is to develop a comprehensive strategy in reducing the incidence and severity of OHSS in in-vitro fertilisation (IVF) cycles. Our short term aim (2-3 years) is to test the ability of the dopamine receptor agonist cabergoline in reducing the incidence and severity of OHSS in high risk women undergoing controlled ovarian hyperstimulation (COH) in fresh IVF cycles through a reduction in vasoactive cytokine levels, specifically in serum vascular-endothelial growth factor (VEGF).\n\nSpecifically we will:\n\n1. Conduct a randomised double-blind placebo-controlled trial in women at high risk of developing OHSS during a fresh COH-IVF cycle\n2. Investigate the serum and follicular fluid levels for potential biomarkers of OHSS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with more than 20 oocytes collected after COH in both gonadotropin-releasing hormone (GnRH) agonist and antagonist cycles\n\nExclusion Criteria:\n\n* Patients with allergy to dopamine agonists\n* Patients who undergo in-vitro maturation cycles\n* Patients where GnRH analogues have been used to trigger oocyte maturation in antagonist cycles'}, 'identificationModule': {'nctId': 'NCT01535859', 'briefTitle': 'Study of Cabergoline for Prevention of Ovarian Hyperstimulation Syndrome (OHSS) in In Vito Fertilization Cycles and Derivation of OHSS Biomarkers', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'A Randomised Controlled Trial of Cabergoline Prophylaxis for Ovarian Hyperstimulation Syndrome in IVF Cycles and Derivation of Biomarkers for OHSS.', 'orgStudyIdInfo': {'id': 'KNMRCNIG1031'}, 'secondaryIdInfos': [{'id': 'NMRC/NIG/1029/2010', 'type': 'OTHER_GRANT', 'domain': 'National Medical Research Council'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cabergoline', 'interventionNames': ['Drug: Cabergoline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cabergoline', 'type': 'DRUG', 'otherNames': ['Dostinex'], 'description': 'Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.', 'armGroupLabels': ['Cabergoline']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet daily for 8 days.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Marianne Sybille Hendricks, MBBS, MRCOG', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}